Regulatory Documentation Specialist

Job Summary

Supporting the Regulatory Operations team, the contract Regulatory Operations Documentation Specialist will assist in the preparation, formatting, and quality control of submission-related documentation for electronic submission in a remote capacity.

Key responsibilities

• Support document formatting and quality control in alignment with submission standards
• Assist in the remediation and quality control of PDF documents to ensure regulatory compliance
• Archive and manage communications with health authorities and retrieve documents from offsite storage facilities

Required qualifications

• High school degree required; Associate's degree preferred
• Pharmaceutical industry experience is a plus, but not required
• Proficient in MS Office and Adobe Acrobat
• Experience with database systems; Veeva is a plus
• Experience with ISI Toolbox or equivalent software packages